REGULATORY AND EVIDENCE

Regulation, Certification and Evidence Center

Evidence delivery undertakes the verification of requirements, structure, materials, processes and products, and provides traceable basis for scale-up and production line introduction review.

Check boundaries:The page is compiled from official sources available on 2026-07-18 and is only used for knowledge navigation and statement gating of food and beverages, beauty and personal care, medicine and medical care, and specialty paper-based packaging, and does not constitute legal, testing or certification opinions.

Let’s break down the five most confusing concepts first.

The object of the declaration must be clear to the emulsion, dry film, coated paper, empty packaging or complete packaging after filling, and be bound to the market, use, method, version and valid evidence.

Biobased ≠ Biodegradable

Biobased content describes the proportion of source carbon or other specified calibers and does not prove degradable, compostable, recyclable, food contact or low carbon.

Biodegradable ≠ Compostable certified

The environment, time, method, complete product structure, certification body, certificate scope and logo authorization must be stated.

Industrial compost ≠ Home compost

Industrial composting routes such as EN 13432 do not certify home composting, nor do raw material certificates automatically cover final packaging.

Paper-based packaging ≠ automatically recyclable

Complete printed coated products need to be tested according to target market methods and evaluation protocols, and technical recyclability does not mean collection in every region.

No intentionally added PFAS ≠ Zero detection of total fluorine or PFAS

Formulation intent, supply chain documentation, total fluorine screening, targeted PFAS or organofluorine analysis and market regulatory dossiers answer different questions.

PFAS uses five parallel dimensions of evidence and does not create an overall score for “more fluoride-free.”

Completion of any one dimension cannot automatically replace other dimensions. Before using "No Intentionally Added PFAS" externally, you still need to confirm the object, version, supply chain coverage and disclosure permissions.

PFAS / FORMULARecipe declaration status

Check all intentionally added components and related processing aids, and indicate the declaration object and version.

PFAS / SUPPLYSupply chain document coverage

Document key ingredient claims, gaps, supplier changes and cross-contamination risks.

PFAS / SCREENTotal fluoride screening status

Shows method, limit of detection, limit of quantification, batch, and screening boundaries and does not equate total fluoride with PFAS.

PFAS / ANALYSISSpecial analysis status

Document targeted PFAS, total organofluorine, extractable organofluorine, or precursor analysis by project.

PFAS / MARKETtarget market profile

Form conclusions by jurisdiction, applicable date, complete structure, test methods and technical documentation.

Applicable time:Article 5(5) of Regulation (EU) 2025/40 applies to PFAS limits for food contact packaging from 2026-08-12; the project combines the applicable date with the target market organization's compliance assessment.

Food contact conclusions must bind the market, use and complete structure.

"FDA certified food grade lotion" is not a professional expression. Any route to market is jointly evaluated from ingredient authorization, intended use, food type, temperature, time, coating weight, migration, sensory and change control.

INPUTIntended use

Direct or indirect contact, food type, temperature, time and single or repeated use.

OBJECTcomplete structure

Paper, coatings, polymers, inks, varnishes, adhesives and sealants.

AUTHORITYcomponent path

Regulations, announcements, FCN, authorized suppliers, specification limits and traceability documents.

TESTMigration and the senses

Evaluate and identify NIAS risks by simulant, condition, sample version, and method.

GMPManufacturing and traceability

Batch, dry cure, cross-contamination, supplier and recipe change control.

RELEASEmarket conclusion

Form conditional representations only for specified versions, structures, uses, and target markets.

Chinese standard mapping:The actual structure may involve both GB 4806.1, 4806.8, 4806.7, 4806.10, 4806.13, 4806.14, 4806.15, GB 9685 and corresponding method standards. The platform must manage release dates, implementation dates, superseded versions, and transition status.

Standards, certification schemes, labels and local systems are displayed hierarchically.

The following is a path navigation, not the certification status of Bioten™ products. The official certificate must bind the product, version, thickness, color, ink, adhesive, serial number, validity period and public catalog one-to-one.

Paper stream recyclable

Methods and protocols: CEPI V3 with 4evergreen or Target Market Evaluation Agreement

Can explain: Complete package performance of pulping, screening and sheet formation in designated laboratory processes.

Can't explain"CEPI certified" or guaranteed collection in all areas.

European industrial composting

Standards and plans: EN 13432; Seedling, DIN CERTCO, OK compost INDUSTRIAL, etc.

Can explain: Certification of industrial composting with specific end products within the scope of the certificate.

Can't explainHome composting, curbside collection acceptance or other regional certificates.

BPI Commercial and Home Composting

Standards and plans: Business track is based on ASTM D6400; Home track is based on NF T 51-800

Can explain: The status of a specific product within the BPI catalog and certificate scope.

Can't explainWhen certified raw materials are used, the final paper cup or packaging is automatically certified.

Australia and New Zealand Compost Path

Standards and plans: AS 4736 Commercial Composting; AS 5810 Home Composting; ABA Labeling System

Can explain: Product status within the scope of official certificate and logo authorization.

Can't explainAll local FOGO or roadside systems must be accepted.

Biobased content

Method: ASTM D6866 and other target plan approval methods

Can explain: Clarify the proportion of bio-based carbon to total organic carbon at the sample boundary.

Can't explainBio-based mass ratio, or it can be deduced from this that it is degradable, recyclable, and low-carbon.

Fiber source

System: FSC, PEFC and other chain supervision and labeling rules

Can explain: Fiber origin and supply chain management status within the scope of the certificate.

Can't explainPackaging is automatically recyclable, compostable, food contact suitable or low carbon.

Test terms are only meaningful when the condition is complete.

The solution passport shows the actual standard version used in the report; the knowledge card also has a "current version" field. Standard updates will not automatically rewrite old reports to be tested against the new version.

Cobb and leakage

Cobb describes the amount of water absorbed by paper and cardboard within a specified period of time, and does not equate to waterproofing, leakage, or cutting edges.

Kit vs. actual grease

Kit is a screening grade for grease resistance and does not equal actual packaging performance across all greases, temperatures and contact times.

OTR and WVTR

Temperature, relative humidity, orientation, sample status and method version must be shown and cannot be directly equated to package shelf life.

Senses and NIAS

The simulation conditions and methods must be explained for the senses; NIAS is the subject of risk identification and assessment, and cannot be closed as a whole with just one test.

ISO 11607

It is only used for the verification of materials, sterile barriers, packaging systems and forming and sealing processes of terminally sterilized medical devices and cannot be extrapolated to ordinary pharmaceutical boxes.

Version management:Current data indexes include ASTM D6866-24a, D6868-21, D8410-22, D3985-24, F1249-25, as well as ISO 11607-1:2019, ISO 11607-2:2019 and AMd 1:2023; project records are synchronized with associated report versions and agency validation scopes.

Check the claim first, then prepare the evidence.

Put the product title or slogan to be used into the rule checker, first identify the object, market, method and certificate gaps, and then enter manual review.

BIOTEN DEVELOPER

Bring this object back into the development loop.

Continue defining variables, validation requirements and information access, or submit a development task for manual pre-review.